To conduct surveillance for abuse, misuse, overdose, addiction, and death and to evaluate if the REMS meets its surveillance goals, and if it does not, to modify it appropriately based on the metrics. Briefly, therefore, the overall surveillance objective is to evaluate for trends before and after the shared REMS is implemented to collectively assess for changes in abuse, misuse, overdose, addiction, and death for different risk groups and settings.
Study Type
OBSERVATIONAL
Enrollment
26,500
Poisson regression will be used to compare changes in rates of abuse, misuse, overdose, and death and other outcomes over time within the ER/LA opioid group to changes in rates among the comparator groups
Time frame: Review over period from January 2010 to December 2016
Mean number of dosing units per prescriptions dispensed across time for the ER/LA REMS drug group
Time frame: Review over period from January 2010 to December 2016
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